A Multi-Institutional Phase II study of Radiation and GW572016 (Lapatinib) for Patients with Stage III-IV Head and Neck Cancer Who Cannot Tolerate Concurrent Chemoradiotherapy

Summary:
Lapatinib is an experimental drug, for the treatment of advanced head and neck cancer.  It is thought that Lapatinib may slow or stop cancer from growing.  It is also thought that Lapatinib may specifically kill part or all of cancer tissue.  However, this has not yet been proven.  Both chemotherapy (given by injection into the veins) and radiotherapy (high energy rays used to destroy cancer cells) are commonly used for treating head and neck cancer.  However, either your medical condition does not allow you to receive chemotherapy with the radiation due to its side effects or you or your doctor does not feel that chemotherapy with the radiation is the best choice for you. Therefore, this study will test the benefit of combining Lapatinib with radiation treatment for your cancer. It is hoped that by giving Lapatinib together with radiation will increase the radiation effect on cancer and increase cancer cell kill without increasing the side effects.

Eligibility:

• Age 18 and older
• Newly diagnosed stage III-IV HNSCC, pathologically confirmed
• No evidence of distant metastasis
• No prior radiation therapy to the head and neck sites

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